BIOKIN PHARMACEUTICAL(SH:688506) Mei Ri Jing Ji Xin Wen·2025-11-18 05:36Core Viewpoint - BaiLi TianHeng's innovative drug, iza-bren, has achieved significant milestones in its Phase III clinical trial for advanced esophageal squamous cell carcinoma, marking a critical breakthrough in the company's research pipeline [1][2][3] Group 1: Clinical Trial Results - The Phase III trial of iza-bren reached both primary endpoints of progression-free survival (PFS) and overall survival (OS), indicating its potential to meet the substantial clinical needs in post-line treatment for esophageal squamous cell carcinoma [1][2] - In earlier Phase I data published in July, iza-bren demonstrated a notable objective response rate (ORR) of 39.6% and a median OS of 11.5 months among evaluable patients [3][4] - The optimal dosing of 2.5 mg/kg showed a doubling effect in both median PFS (5.4 months vs. 2.7 months) and median OS (11.5 months vs. 5.6 months) compared to the 2.0 mg/kg group, providing a solid basis for the ongoing Phase III study [4] Group 2: Broader Cancer Treatment Potential - Iza-bren's potential is being validated across multiple cancer types, with promising data in nasopharyngeal carcinoma showing an ORR of 54.6% compared to 27.0% in the control group, and a median PFS of 8.38 months [4] - In the lung cancer market, iza-bren achieved a 100% ORR in a Phase II study for EGFR-mutant non-small cell lung cancer, showcasing its significant therapeutic potential [5] - The drug also demonstrated an 80.0% ORR in a subgroup of patients with extensive-stage small cell lung cancer, reinforcing its capability to impact major cancer types [6] Group 3: Strategic Decisions and Market Position - BaiLi TianHeng decided to postpone its Hong Kong IPO, reflecting a strategic retreat amid market volatility and a reassessment of valuation dynamics in the IPO landscape [7][8] - The company has sufficient financial resources, with cash reserves of 6.086 billion RMB, to support its ongoing operations and research plans for the coming years [8] - The pricing strategy for the Hong Kong IPO indicated confidence in the future potential of its innovative drug pipeline, as the discount compared to A-shares was only 1.8% to 12.2%, significantly lower than the typical 20% to 40% for A+H listings [8]